A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads
Information source: Stryker European Operations BV
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthroplasty, Replacement, Hip
Intervention: Trident cup, X3 inserts, 28 mm head (Device); Trident cup, X3 inserts, 40 mm head (Device); Symax stem (Device); Accolade TMZF stem (Device)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Stryker European Operations BV Official(s) and/or principal investigator(s): Ide C. Heyligers, MD, Principal Investigator, Affiliation: Atrium Medical Center, Heerlen, The Netherlands
Summary
Prospective, singlecentre, randomized clinical study; series of patients with a 5-years
patient evaluation period.
Clinical Details
Official title: A Comparative Study of In-vivo Wear Between 28 mm and 40 mm Metal Heads With Highly Cross Linked (X3) Acetabular Polyethylene Insert in the Hemispherical Trident Cup
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS (Hip Analysis Suite, a software for the determination of polyethylene wear on digital radiographs).
Secondary outcome: Harris Hip Score (HHS) patient questionnaireMerle D'Aubergine Score (MdA)
Detailed description:
This is a single centre randomized clinical outcomes study. The Symax stem or Accolade TMZF
(Titan, Molybdenum, Zirconium, Ferrum) in combination with the Hemispherical Trident cup, X3
inserts, 28 and 40 mm Metal heads are the primary components to be implanted for evaluation.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and non pregnant female patients between 18-75 years of age.
2. Patients requiring uncemented primary total hip arthroplasty (THA), suitable for the
use of the Symax stem
3. Patients with a diagnosis of osteoarthritis (OA), rheumatoid arthritis (RA),
avascular necrosis (AVN) or post-traumatic arthritis (TA).
4. Patients who understand the conditions of the study and are willing and able to
comply with the post-operative scheduled clinical and radiographic evaluations and
the prescribed rehabilitation
5. Patients who signed the specific Informed Consent Form prior to surgery
Exclusion Criteria:
1. Patients who require revision of a previously implanted THA
2. Patients who had a THA on contra-lateral side within the last 1 year.
3. Patients who had a THA on contralateral side more than 1 year ago and the
rehabilitation period outcome was considered unsatisfactory or not good. (Patients
with contra-lateral THA > 1 year ago with good outcome (Harris Hip Score > 85) can be
included in the study).
4. Patients who will need lower limb joint replacement for another joint within one
year.
5. Bilaterally operated patient.
6. Patients who have had a prior procedure of acetabular osteotomy.
7. Patients with active or suspected infection.
8. Patients with malignancy - active malignancy
9. Patients with a diagnosed systemic disease that would affect the subject's welfare or
overall outcome of the study (i. e. severe osteoporosis, Paget's disease, renal
osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of
physiologic dose requirements.
10. The patient has a neuromuscular or neurosensory deficit which would limit the ability
to assess the performance of the device or the patient has a neurological deficit
which interferes with the patient's ability to limit weight bearing or places an
extreme load on the implant during the healing period.
11. Female patients planning a pregnancy during the course of the study.
12. Patients with systemic or metabolic disorders leading to progressive bone
deterioration.
13. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to
be compliant with the prescribed post-operative routine and follow-up evaluation
schedule.
14. Patients with other severe concurrent joint involvements which can affect their
outcome.
15. Patients with other concurrent illnesses which are likely to affect their outcome
such as sickle cell anaemia, systemic lupus erythematosus, psoriasis, Insulin
dependent Type I diabetes or renal disease requiring dialysis.
16. Surgeries to be performed with navigation and/or robot-assisted instruments.
17. Patient with a known sensitivity to device materials.
Locations and Contacts
Atrium Medical Center, Heerlen, Netherlands
Additional Information
Starting date: October 2010
Last updated: August 13, 2015
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